Vitamin C and Atrial Fibrillation After Cardiac Surgery
|Atrial Fibrillation||Drug: Ascorbic Acid Other: Identical Placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Effect of Ascorbic Acid on the Incidence of Post-operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery|
- Post-operative atrial fibrillation [ Time Frame: Patients will be followed for the entire hospital stay, with an expected average of 5 days ]
- Hospital length of stay [ Time Frame: 30 Days ]
- Intensive care unit length of stay [ Time Frame: 30 Days ]
- Stroke [ Time Frame: 30 Days ]
- Transient ischemic attack [ Time Frame: 30 Days ]
- Mortality [ Time Frame: 30 Days ]
- Hospital Readmission for atrial fibrillation [ Time Frame: 30 Days ]
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
|Experimental: Ascorbic acid||
Drug: Ascorbic Acid
Two 1 g capsules the evening prior to surgery, followed by one 1 g capsule every 12 hours starting the morning of the first postoperative day for 5 days.
Other Name: Vitamin C
|Placebo Comparator: Placebo||
Other: Identical Placebo
Two capsules the evening prior to surgery, followed by one capsule every 12 hours starting the morning of the first postoperative day for 5 days.
The development of atrial fibrillation (AF) following cardiac surgery is relatively common, occurring in approximately 25-60% of patients. Coronary artery bypass graft surgery (CABG) carries the lowest risk of AF development, with an incidence of approximately 25-30%, followed by cardiac valve and combined CABG/cardiac valve surgeries, with incidences up to 60%. AF development in patients undergoing cardiac procedures has been linked to increases in postoperative morbidity and mortality, including an increase in readmission to the ICU, stroke, reintubation, and 30-day and 6-month mortality. Patients who develop AF have also been shown to experience longer hospital stays, both in the ICU and overall.
While some other medications have been shown to decrease the risk of AF development, the use of beta-blockers peri- and postoperatively have shown the most promise, and are the standard of care for patients undergoing CABG surgery. However, patients experiencing AF have been shown to experience cardiac production of peroxynitrite, corresponding to a hypothesis that AF occurs through oxidative stress. Due to this correlation, supplementation of ascorbate has been proposed as a treatment to reduce the risk of AF development following cardiac surgery. Ascorbate is a potent peroxynitrite antagonist, and may therefore reduce oxidative stress and AF development following cardiac surgery. This trial aims to assess the efficacy of ascorbic acid in reducing the incidence of postoperative AF in patients undergoing elective or urgent CABG surgery, cardiac valve surgery, or a combination of the two. Our hypothesis is that ascorbic acid will decrease the incidence of postoperative AF development.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01580683
|United States, Pennsylvania|
|Regional Hospital of Scranton|
|Scranton, Pennsylvania, United States, 18510|
|Principal Investigator:||Scott Bolesta, Pharm.D.||Wilkes University|